CN110430843B

CN110430843B - Medical device shaft including a liner

Info

Publication number: CN110430843B
Application number: CN201880018182.1A
Authority: CN
Inventors: 凯文·罗伯特·波普; 丹尼尔·J·福斯特; 布拉德利·S·斯威拉; 克里斯托弗·杰伊·谢夫
Original assignee: Boston Scientific Scimed Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2017-03-14
Filing date: 2018-03-14
Publication date: 2022-06-07
Anticipated expiration: 2038-03-14
Also published as: WO2018170088A1; JP6861294B2; US10966829B2; CN110430843A; US20180263771A1; EP3595595A1; JP2020508787A

Abstract

Medical devices and methods of making and using medical devices are disclosed. An example delivery system for an implantable medical device includes an inner shaft having a proximal end region, a distal end region, and a non-circular lumen extending therethrough. The delivery system also includes a tensile member extending at least partially between the proximal and distal end regions, a deployment catheter disposed along an outer surface of the shaft, and an actuation shaft disposed within the non-circular lumen. Further, the actuation shaft is coupled to the implantable medical device, and translation of the actuation shaft transitions the implantable medical device from a first position to a second position.

Description

Medical device shaft including a liner

Cross Reference to Related Applications

According to 35u.s.c. § 119, the present application claims priority interest from united states provisional application serial No. 62/471,100 filed 3, 14, 2017, the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to medical devices and methods of manufacturing medical devices. More particularly, the present invention relates to medical devices including a reduced profile inner liner.

Background

A wide variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and may be used according to any of a variety of methods. The known medical devices and methods each have certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of making and using medical devices.

Disclosure of Invention

The present invention provides design, materials, manufacturing methods and alternatives for use of medical devices. An example delivery system for an implantable medical device includes an inner shaft having a proximal end region, a distal end region, and a non-circular lumen extending therethrough. The delivery system also includes a tensile member extending at least partially between the proximal region and the distal region, a deployment catheter disposed along an outer surface of the shaft, and an actuation shaft disposed within the non-circular lumen. Further, the actuation shaft is connected to the implantable medical device, and translation of the actuation shaft transitions the implantable medical device from the first position to the second position.

Alternatively or additionally to any of the embodiments above, wherein the implantable medical device comprises an implantable heart valve.

Alternatively or additionally to any of the embodiments above, wherein the inner shaft includes pairs of tensile members disposed along opposite sides of the inner shaft.

Alternatively or additionally to any of the embodiments above, further comprising a pair of actuating shafts disposed within the non-circular lumen, and wherein the non-circular lumen is designed to limit twisting of the actuating shafts within the lumen.

Alternatively or additionally to any of the embodiments above, wherein the inner shaft is configured to rotate, translate, or both rotate and translate relative to the deployment catheter.

Alternatively or additionally to any of the embodiments above, further comprising a first tubular member extending within the non-circular lumen, and wherein the first tubular member is configured to receive a guidewire extending therein.

Alternatively or additionally to any of the embodiments above, further comprising a second tubular member extending within the non-circular lumen, and wherein the actuation shaft extends within the second tubular member.

Alternatively or additionally to any of the embodiments above, wherein the non-circular lumen is designed to limit twisting of the first tubular member and the second tubular member.

Alternatively or additionally to any of the embodiments above, wherein the tensile member comprises a wire.

Alternatively or additionally to any of the embodiments above, wherein the tensile member includes a polymer.

Another example delivery system for an implantable heart valve, comprising:

an inner shaft having a distal end region, an oval cavity extending therethrough, and a tensile member extending at least partially between the proximal end region and the distal end region;

a deployment catheter disposed along an outer surface of the shaft; and

an actuating shaft disposed within the oval cavity;

wherein the actuation shaft is connected to the implantable medical device;

wherein translation of the actuation shaft causes the heart valve to transition from the first position to the second position.

Alternatively or additionally to any of the embodiments above, further comprising a pair of actuation shafts disposed within the oval lumen, and wherein the oval lumen is designed to limit twisting of the actuation shafts within the oval lumen.

Alternatively or additionally to any of the embodiments above, further comprising a first tubular member extending within the oval lumen, and wherein the first tubular member is configured to receive a guidewire extending therein.

Alternatively or additionally to any of the embodiments above, further comprising a second tubular member extending within the oval lumen, and wherein the actuation shaft extends within the second tubular member.

Alternatively or additionally to any of the embodiments above, wherein the oval cavity is designed to limit twisting of the first and second tubular members.

A method for delivering an implantable medical device, the method comprising:

Advancing a medical device delivery system to a target site within a heart, the medical device delivery system comprising:

an inner shaft having a proximal end region, a distal end region, a non-circular lumen extending therethrough, and a tensile member extending at least partially between the proximal and distal end regions;

a deployment catheter disposed along an outer surface of the shaft;

an actuating shaft disposed within the non-circular cavity; and

an implantable heart valve connected to the actuation shaft;

retracting the deployment catheter relative to the inner shaft;

translating an actuation shaft relative to the inner shaft, wherein translation of the actuation shaft transitions the implantable medical device from the collapsed position to the deployed position.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. More particularly, the following figures and detailed description illustrate these examples.

Drawings

The invention may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIG. 1 is a side view of an example medical device system;

FIG. 2 is a perspective view of a portion of the shaft of the medical device shown in FIG. 1;

FIG. 3 is a perspective view of an exemplary inner catheter of the medical device system shown in FIGS. 1 and 2;

FIG. 4 is a perspective view of a catheter in another example of the medical device system shown in FIGS. 1 and 2;

fig. 5 is a cross-sectional view of an exemplary inner catheter of the medical device system shown in fig. 4.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Detailed Description

To the extent that the following defined terms are used, these definitions should apply, unless a different definition is set forth in the claims or elsewhere in this specification.

All numerical values are herein assumed to be modified by the term "about," whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. Such expressions do not necessarily imply, however, that all embodiments include the particular features, structures and/or characteristics. Further, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is understood that such feature, structure, and/or characteristic may also be used in other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

The following detailed description should be read with reference to the drawings, in which like structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, illustrate exemplary embodiments and are not intended to limit the scope of the disclosure.

Diseases and/or medical conditions affecting the cardiovascular system are worldwide prevalent. Traditionally, treatment of the cardiovascular system is typically performed by directly accessing the affected parts of the system. For example, treatment of an occlusion in one or more of the coronary arteries has traditionally been treated with coronary artery bypass surgery. As can be readily appreciated, such therapies are quite invasive for the patient and require significant recovery time and/or treatment. More recently, less invasive therapies have been developed, for example, where an obstructed coronary artery can be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance between patients and clinicians.

Some of the more common medical conditions may include, or be the result of, inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic or mitral valves can have serious effects on humans and can lead to serious health and/or death if not properly treated. Treatment of defective heart valves presents other challenges, as the treatment often requires repair or complete replacement of the defective valve. Such therapies can be highly invasive to the patient. Disclosed herein are medical devices that may be used to deliver a medical device to a portion of the cardiovascular system to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve, a replacement mitral valve, etc.). In addition, the devices disclosed herein can deliver replacement heart valves percutaneously, and thus can be far less invasive for the patient. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.

The figures illustrate selected components and/or arrangements of a medical device system 10, such as that schematically illustrated in fig. 1. It should be noted that for simplicity, some features of the medical device system 10 may not be shown, or may be schematically shown, in any given figure. Additional details regarding some of the medical device system 10 components may be shown in more detail in other figures. The medical device system 10 may be used to deliver and/or deploy a variety of medical devices to a number of locations within an anatomical structure. In at least some embodiments, the medical device system 10 can include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a medical implant 16, such as a replacement/prosthetic heart valve. However, this is not intended to be limiting, as the medical device system 10 may also be used for other interventions, including valve repair, annuloplasty, delivery of implantable medical devices (e.g., such as stents, grafts, etc.), and the like, or other similar interventions.

The medical device system 10 can generally be described as a catheter system that includes an outer sheath 12 and an inner catheter 14 (a portion of which is shown in phantom in fig. 1), the inner catheter 14 extending at least partially through a lumen of the outer sheath 12, and a medical implant 16 (e.g., a replacement heart valve implant), the medical implant 16 being coupleable to the inner catheter 14 and disposed within the lumen of the outer sheath 12 during delivery of the medical implant 16. In some embodiments, the medical device handle 18 may be disposed at the proximal end of the outer sheath 12 and/or inner catheter 14 and may include one or more actuation mechanisms associated therewith. In other words, the tubular member (e.g., outer sheath 12, inner catheter 14, etc.) can extend distally from the medical device handle 18. In general, the medical device handle 18 may be designed to manipulate the position of the outer sheath 12 relative to the inner catheter 14, and/or to aid in the deployment of the medical implant 16.

In use, the medical device system 10 can be percutaneously advanced through the vasculature to a position adjacent a region of interest and/or a treatment location. For example, in some embodiments, the medical device system 10 may be advanced through the vasculature to a location adjacent a defective native valve (e.g., aortic valve, mitral valve, etc.). Alternative methods of treating defective aortic valves and/or other heart valves with the medical device system 10 are also contemplated. During delivery, the medical implant 16 may be disposed within the lumen and/or distal end of the outer sheath 12 in a generally elongate and low-profile "delivery" configuration, as schematically illustrated in fig. 1, for example. Once positioned, the outer sheath 12 may be retracted relative to the medical implant 16 and/or the inner catheter 14 to expose the medical implant 16. In some cases, the medical implant 16 may be self-expanding such that exposure of the medical implant 16 deploys the medical implant 16. Alternatively, the medical implant 16 may be expanded/deployed using the medical device handle 18 to convert the medical implant 16 into a generally shortened and high profile "deployed" configuration suitable for implantation within the anatomy. For example, in some instances, the inner catheter (or components thereof) may be coupled to the medical implant 16, whereby actuation of the inner catheter 14 relative to the outer catheter 12 and/or the medical implant 16 may deploy the medical implant 16 within the anatomy. When the medical implant 16 is properly deployed within the anatomy, the medical device system 10 can be disconnected, and/or released from the medical implant 16, and the medical device system 10 can be removed from the vasculature, leaving the medical implant 16 in place in a "released" configuration.

It should be understood that during delivery and/or deployment of an implantable medical device (e.g., medical implant 16), portions of the medical device system 10 may need to be advanced through tortuous and/or stenotic body lumens. Accordingly, it may be desirable to utilize components and design medical delivery systems (e.g., such as medical device system 10 and/or other medical devices) that reduce the profile of portions of the medical device while maintaining sufficient strength (compression, torsion, etc.) and flexibility of the overall system.

FIG. 2 illustrates a portion of an example shaft 20 that may reduce the profile of portions of a medical device while maintaining sufficient strength (compression, torsion, etc.) and flexibility of the overall system. In some examples, the shaft 20 may be used as the inner catheter 14 in the medical device system 10 shown in fig. 1. However, the shaft 20 may be other components of the medical device system 10, components of different medical device systems (e.g., stent delivery systems, angioplasty systems, biopsy systems, etc.), any other medical device that requires a reduced profile design, etc.

The shaft 20 may include an inner member or liner 22. The inner liner 22 may include a number of features as discussed herein. An outer member 28 may be disposed along an outer surface of the inner liner 22. The outer member 28 may be designed to translate and/or rotate relative to the liner 22. For example, it should be appreciated that the liner 22 may translate longitudinally or twist radially within the outer member 28 as the shaft 20 is advanced through the anatomy.

The inner liner 22 may include a number of features. For example, inner liner 22 may include one or more tensile members 30a/30 b. Tensile members 30a/30b may take the form of wires (e.g., metal wires), braids, cables, stranded cables, composite structures, and the like. In one example, the tension members 30a/30b are both wires. In another example, the tension members 30a/30b are both metal braids. The braid may also include axial filaments made of a suitable polymer or metal (e.g., aramid). Tensile members 30a/30b may be made of the same material and/or have the same configuration. Alternatively, tensile members 30a/30b may be different from one another. Furthermore, although FIG. 2 illustrates inner liner 22 as including two tensile members 30a/30b, this is not intended to be limiting. Other numbers of tensile members 30a/30b are contemplated, such as one, three, four, five, six, seven, or more.

The inner liner 22 may also include a cavity 32. In some examples, the first tubular member 34 may be disposed within the cavity 32. The first tubular member 34 may define a guidewire lumen 35 through which a guidewire 36 may extend. A second tubular member 38 may also be disposed within the cavity 32. The second tubular member 38 may define a cavity 39 through which the actuating member 40 may extend. As described above, the actuation member 40 may be joined and/or attached to the medical implant 16. Translation of the actuation member 40 may transition the implant 16 from the first collapsed configuration to the second deployed configuration.

Fig. 3 shows the liner 22 described in relation to fig. 1 to 2. As shown in FIG. 3 and described above, liner 22 may include a pair of tensile members 30a/30b that are located on opposite sides of cavity 32. Fig. 3 also illustrates that the cavity 32 may be shaped to limit twisting of the first and second

tubular members

34, 38 relative to one another. For example, FIG. 3 shows that the cavity 32 may be non-circular. For example, the shape of the cavity 32 may be oval, square, rectangular, triangular, combinations thereof, and the like. These are merely examples. The form of the inner liner 22 may vary. For example, the inner liner 22 may include various shapes in combination with a single lumen or multiple lumens. Further, the liner 22 may be void of cavities.

It should be appreciated that as the liner 22 rotates within the cavity of the outer member 28, the non-circular shape of the cavity 32 may force both the first and second

tubular members

34, 38 to maintain their respective spatial relationships, as shown in fig. 2. In other words, the shape of the cavity 32 forces the first and second

tubular members

34, 38 to remain in their respective positions relative to each other regardless of bending, rotation, flexing, etc. of the liner 22.

Although fig. 2 illustrates the cavity 32 as being designed to receive the first and second

tubular members

34, 38, it is contemplated that the cavity 32 may be configured to receive more or less than two separate tubular members. For example, the cavity 32 may be formed to accommodate one, two, three, four, five, six, seven, eight, or more cavities. Further, it is contemplated that the particular shape of the cavity 32 may be designed to match the outer profile of any number of cavities grouped together in common. For example, although not shown in the figures, it should be understood that the triangular cavity 32 may match the outer profile of three circular tubular members grouped together offset from each other by about 120 degrees. This is not intended to be limiting. Rather, the cavity 32 may be formed to match the contours of any collection of tubular members having any given outer contour. As discussed above, matching the shape of the lumen 32 to the profile of the tubular members located therein limits the ability of the tubular members to twist relative to each other within the lumen 32.

It should also be appreciated that varying the shape of the cavity 32 may help to reduce the overall profile of the liner 22, and thus the shaft 20. For example, varying the shape of the cavity 32 may allow for a reduction in the wall thickness separating the various cavities extending within the liner 22. Reducing the wall thickness separating the various cavities may allow the overall profile of the liner 22 and/or shaft 20 to be much smaller than existing liner/shaft designs.

Further, it should be understood that it may be desirable to alter the shape of the outer surface profile of the liner 22. For example, fig. 4 illustrates another example liner 122. The liner 122 may be similar in form and function to the other liners discussed herein. For example, liner 122 may include an interior cavity 132 and two tensile members 130a/130 b. However, as shown in fig. 4, the liner 122 may also include an outer surface profile that includes one or more longitudinally extending channels 121 (e.g., grooves, slots, etc.) extending along its length. As shown in fig. 4, each of channels 121 may include a curved portion that, in some examples, follows the contours of lumen 132 and both tensile members 130a/130 b.

Figure 5 illustrates a cross-sectional view of the inner liner 122 shown in figure 4. However, FIG. 5 also illustrates an outer member 128 (which may be similar in form and function to the outer member 28 discussed above) located on the inner liner 122. It will be appreciated from fig. 5 that one or more of the channels 121 may create one or more "pseudo-cavities" (e.g., spaces, openings, holes, etc.) that extend the length of the liner 122 and the outer member 128 between the outer surface of the inner liner 122 and the inner surface of the outer member 128. In some instances, it may be desirable for wires, cables, etc. to extend (e.g., be positioned) through the channel 121. It is contemplated that wires, cables, etc. that may extend through channel 121 may be complementary to both tensile members 130a/130 b.

Materials that may be used for various components of the medical devices and/or systems disclosed herein (e.g., shaft 20 and/or other shafts disclosed herein) may include those typically associated with medical devices. For simplicity, the following discussion refers to the shaft 20. However, this is not intended to limit the devices and methods described herein, as the discussion is applicable to other shafts and/or components of the medical devices and/or systems disclosed herein, including various bead members, barrel members, and the like.

The shaft 20 may be made of metal, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable polymers may include Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont

) Polyether block estersPolyurethanes (e.g., Polyurethane 85A), polypropylenes (PP), polyvinyl chlorides (PVC), polyether esters (e.g., available from DSM Engineering Plastics)

) Ether-or ester-based copolymers (e.g., butylene/poly (alkylene ether) phthalate) and/or other polyester elastomers such as those available from DuPont

) Polyamides (e.g. available from Bayer)

Or available from Elf Atochem

) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, for example, available under the trade name PEBA)

Obtained), ethylene vinyl acetate copolymer (EVA), silicone, Polyethylene (PE), High Density Polyethylene (HDPE), polyester, Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g.,

) Ultra High Molecular Weight (UHMW) polyethylene, polypropylene, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), Polyetheretherketone (PEEK), Polyimide (PI), Polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly (paraphenylene terephthalamide) (e.g.,

) Polysulfone, nylon-12 (such as available from EMS American Grilon)

) Perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-b-styrene) (e.g., SIBS and/or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer/metal composites thereof, and the like. In some embodiments, the jacket may be blended with a Liquid Crystal Polymer (LCP).

Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steel; nickel titanium alloys, such as linear elastic and/or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as

625, a first step of; UNS: N06022, such as

UNS N10276, such as

Others

Alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as

400、

400、

400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as

Etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as

ALLOY

) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, and the like, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as

Etc.), platinum-rich stainless steel, titanium, combinations thereof, etc., or any other suitable material.

In at least some embodiments, part or all of the shaft can also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials that are capable of producing a relatively bright image on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the shaft to determine his position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers (e.g., barium sulfate, bismuth subcarbonate, etc.), and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the shaft 20 to achieve the same result.

In some embodiments, the shaft is given a degree of Magnetic Resonance Imaging (MRI) compatibility. For example, the shaft 20 may be made of a material that does not substantially distort the image and generates a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may generate artifacts in MRI images. The shaft 20 may also be made of a material that the MRI machine is capable of imaging. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as

Etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: r44035, such as

Etc.), nitinol, etc., and others.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. To the extent appropriate, this may include using any of the features of one example embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A delivery system for an implantable medical device, comprising:

A deployment catheter disposed along an outer surface of the inner shaft;

an actuation shaft disposed within the non-circular cavity;

a first tubular member extending within the non-circular lumen, and wherein the first tubular member is designed to accept a guidewire extending therein; and

a second tubular member extending within the non-circular lumen, and wherein an actuation shaft extends within the second tubular member;

wherein the actuation shaft is coupled to the implantable medical device;

wherein translation of the actuation shaft causes the implantable medical device to transition from a first position to a second position.

2. The delivery system of claim 1, wherein the implantable medical device comprises an implantable heart valve.

3. The delivery system of claim 1 or 2, wherein the inner shaft comprises pairs of tensile members disposed along opposite sides of the inner shaft.

4. The delivery system of claim 1, further comprising a pair of actuating shafts disposed within the non-circular lumen, and wherein the non-circular lumen is designed to limit twisting of the actuating shafts within the lumen.

5. The delivery system of claim 3, wherein the inner shaft is configured to rotate, translate, or both rotate and translate relative to the deployment catheter.

6. The delivery system of claim 1, wherein the non-circular lumen is designed to limit twisting of the first and second tubular members.

7. The delivery system of claim 3, wherein the tensile member comprises a wire.

8. The delivery system of claim 3, wherein the tensile member comprises a polymer.

9. A delivery system for an implantable heart valve, comprising:

an inner shaft having a proximal end region, a distal end region, an ovoid cavity extending therethrough, and a tensile member extending at least partially between the proximal and distal end regions;

a deployment catheter disposed along an outer surface of the inner shaft;

an actuation shaft disposed within the oval lumen;

a first tubular member extending within the oval lumen, and wherein the first tubular member is designed to accept a guidewire extending therein; and

a second tubular member extending within the oval lumen, and wherein an actuation shaft extends within the second tubular member;

wherein the actuation shaft is coupled to the implantable heart valve;

wherein translation of the actuation shaft causes the heart valve to transition from a first position to a second position.

10. The delivery system of claim 9, wherein the inner shaft includes pairs of tensile members disposed along opposite sides of the inner shaft.

11. The delivery system of claim 9 or 10, further comprising a pair of actuation shafts disposed within the oval lumen, and wherein the oval lumen is designed to limit twisting of the actuation shafts within the oval lumen.